Photodynamic Therapy Using Silicon Phthalocyanine 4 in Treating Patients With Actinic Keratosis, Bowen's Disease, Skin Cancer, or Stage I or Stage II Mycosis Fungoides

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Completed; Phase 1

Conditions: Precancerous Condition; Lymphoma; Non-melanomatous Skin Cancer

Treatments: Drug: silicon phthalocyanine 4

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00103246

10-03-01 (Other Identifier)

P30CA043703 (U.S. NIH Grant/Contract)

CASE1Y04 (Other Identifier)

CASE-CWRU-1Y04

Details and patient eligibility

About

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy using silicon phthalocyanine 4 may be effective against skin cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using silicon phthalocyanine 4 in treating participants with actinic keratosis, Bowen's disease, skin cancer, or stage I or stage II mycosis fungoides.

Full description

OBJECTIVES:

• Determine the maximum tolerated dose of photodynamic therapy using topically delivered silicon phthalocyanine 4 in participants with actinic keratosis, Bowen's disease, squamous cell or basal cell skin cancer, or stage IA, IB, IIA, or IIB mycosis fungoides.
• Determine the safety and toxicity of this therapy with emphasis on whether it induces photosensitivity in non-treated sites in these participants .
• Determine the antitumor mechanism of this therapy, by monitoring tissue changes via clinical, histological, immunohistochemical, and other biochemical markers, in these participants.
• Determine, preliminarily, the dose of this therapy that results in highest clearing rates in these participants.

OUTLINE: This is a dose-escalation study.

Participants receive topical silicon phthalocyanine 4 (Pc 4). One hour later, participants undergo photodynamic therapy. Treatment repeats weekly for up to 3 weeks (up to 3 total treatments for the same lesion OR up to 3 lesions treated if multiple lesions are present).

Cohorts of 3 participants receive escalating doses of Pc 4 and visible light until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 participants experiences dose-limiting toxicity. Three additional participants are treated at the MTD.

After completion of study therapy, participants are followed for up to 2 weeks.

PROJECTED ACCRUAL: A total of 16-45 participants will be accrued for this study.

Enrollment: 43 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of 1 of the following:

  • Actinic keratosis
  • Bowen's disease
  • Squamous cell skin cancer
  • Basal cell skin cancer
  • Clinical stage IA, IB, IIA, or IIB mycosis fungoides

• Fitzpatrick skin type I-IV

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patient must use effective contraception

• No diabetes mellitus

• No known hypersensitivity to ethanol or propylene glycol

• No significant history of photosensitivity, including diagnosis of any of the following:

  • Porphyria
  • Lupus erythematosus
  • Xeroderma pigmentosum
  • Severe polymorphous light eruption
  • Solar urticaria

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• More than 2 weeks since prior anticancer radiotherapy
• No concurrent radiotherapy

Surgery

• Lesions must be healed after prior biopsy

Other

• More than 2 weeks since prior topical, local, or systemic anticancer therapy

• More than 2 weeks since prior anticancer phototherapy

• More than 2 weeks since prior photosensitizing medications, including any of the following:

  • Tetracyclines
  • Quinolones
  • Psoralens
  • Hydrochlorothiazide
  • Furosemide
  • Trimethoprim-sulfamethoxazole
  • Griseofulvin
  • Nalidixic acid
  • Amiodarone
  • Phenothiazines
  • High-dose nonsteroidal anti-inflammatory drugs

• No other concurrent photosensitizing medications

• No concurrent therapeutic dose of warfarin that may cause excessive bleeding during skin biopsy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Topical silicon phthalocyanine 4 (Pc 4) + photodynamic therapy

Experimental group

Description:

Topical silicon phthalocyanine 4 (Pc 4) followed by photodynamic therapy.

Treatment:

Drug: silicon phthalocyanine 4